1. Field of the Invention
The present invention pertains to a medical system, and more particularly, pertains to glucose medical monitoring diagnostic system for sampling and analyzing blood or any components of the blood for specific readings as to qualities of the blood. One specific use of the present invention is for sensing the accumulating of blood glucose for diabetics. The diagnostic system is a portable, pocket-size, battery operated, diagnostic system including a disposable diagnostic reagent unit and a disposable lancet.
2. Description of the Prior Art
Prior art blood glucose devices have operated on the principle of taking blood from an individual by a variety of methods, such as by a separate needle or lancing device. An individual then had to coat a separate unit carrying chemistry with the blood, time the chemical reaction for about 60 seconds, wipe or remove the blood sample from the unit, and insert the blood-coated unit into a blood glucose meter or make a visual personal comparison against a color standard.
There are numerous blood glucose meters in the marketplace, and most of the instruments consume physical space and are not easily pocketable. The instruments usually have to be carried in a large handbag, or a individual's briefcase, or left at home such as in the bathroom or the bedroom, or on a counter or a table.
The prior art medical apparatuses for sensing blood glucose required that an individual have separately available a needle or lance for extracting blood from the individual, units carrying blood chemistry for creating a chemical reaction with respect to the blood glucose and changing color, and a blood glucose meter for reading the change in color indicating the blood glucose level. The level of blood glucose, when measured by a glucometer, is read from a unit carrying the blood chemistry through the well known process of reflectometers based on the principle of glucose oxidation.
Some of the monitor/reagent unit systems that are now available on the market have multiple sequential steps that the patient must follow at exact time intervals. Each step is subject to error by the patient. As in most monitors, it is the patient's responsibility to periodically calibrate the monitor against known color standards; validate the efficacy of the reagent units and technique by immersing the units in a control solution of known glucose content; and, then comparing the color change visually against the color standard or by using a calibrated monitor. These types of prior art systems are subject of course to human error.
The procedure for obtaining accurate results from the time a drop of blood is placed on a reagent unit pad to the time the pad color change may be read in the glucose monitor is as now described. The patient must stick himself/herself with a lancet. A drop of blood must be squeezed to the surface of the skin. The blood must then be carefully placed on the reagent pad, making sure to cover the pad completely and that the pad is never touched by the finger of the patient to prevent contamination. Once the sample has been applied to the surface of the reagent pad, the patient must press a timer on the monitor. At the end of the timing, the patient must wipe, blot or wash the unit off, using a careful technique. And for most units, the patient must place the reacted reagent unit into the monitor, and press a test button or close a hatch to obtain results. Prior art commercially available comparable reagent units or monitors require operator intervention in a prescribed sequence at exact time intervals. The prior art monitors are subject to operator error, sequence errors, timing errors, and technique errors.
The prior art reagent units are also subject to contamination which may affect accuracy of measurement.
A representative patent is U.S. Pat. No. 4,787,398, same assignee on this patent entitled "Glucose Medical Monitoring System", issued on Nov. 29, 1988.
The present invention overcomes the disadvantages of the prior art by providing an integrated hand-held pocketable blood glucose monitoring meter which includes an attachable disposable lancet, reagent test device for blood glucose. unit carrying a chemical reagent chemistry, and a wick for, transporting the blood to the blood sensing reagent, resulting in a readout of a level of the blood glucose.